Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System

FDA device recall Z-2405-2008 · posted 2008-09-25 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.

Action taken

The initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete and return the enclosed response form within 10 days. In addition, the customers were informed that the contaminated Heparin was used in the following Beckman Coulter, Inc., products: Synchron Theophylline (THE) Reagent (lot # M701460), Synchron Phenytoin (PHY) Reagent and Synchron C-Reactive Protein (CRP) Reagent (lot# M703222, M703266, M703267 & M703268), however Beckman Coulter has verified through testing that the performance of these products are not affected.

Root cause

Process control

Status

Terminated

Product code

LDP

Quantity affected

7764 test kits

Distribution

Nationwide and Canada

Date initiated

2008-07-10

Date posted

2008-09-25

Date terminated

2012-07-11

Location

Brea, CA

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